NCT03420443

Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.

Detailed description

Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray (Gy) during one week preoperatively will be examined. The patients will be divided into three groups with ten patients in each group. One control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. The patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are stored at -80°C until analysis.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oat bran	45 g oat bran.
DIETARY_SUPPLEMENT	Oat bran and blueberry husks	13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
DIETARY_SUPPLEMENT	No oral supplementation	No oral supplementation.

Timeline

• Start date: 2008-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2018-02-05
• Last updated: 2018-02-05